A recent United States statute establishes an expedited pathway for FDA approval of biosimilars (also known as follow-on biologics) – the Biologics Price Competition and Innovation Act (BPCIA), part of the Affordable Care Act. A biologic is a drug derived from a living organism or living cells and is best exemplified by Humira®, the branded antibody for treatment of rheumatoid arthritis. Simply put, a biosimilar is a molecule that copies a branded biologic and is for all practical purposes highly identical to the branded biologic in structure and function.
The FDA biosimilar approval pathway requires filing an application containing information about applicant’s biosimilar, including analytical studies showing similarity to a branded biologic, animal studies assessing toxicity, and clinical studies demonstrating safety, purity and potency. The FDA will likely approve the biosimilar if the application:
- establishes similarity between the applicant’s biosimilar and the branded biologic
- meets certain safety and efficacy requirements
- allows inspection of the biosimilar producing facility.
So far, no biosimilars have been approved by the FDA pursuant to this pathway however, its impact on pharmaceutical litigation cannot be underestimated.
Shortly after a biosimilar application is filed, the applicant must exchange information with the branded biologic holder to resolve which of the brand holders’ patents covering the branded biologic will be litigated by the parties. As part of any litigation strategy, brand holders and biosimilar applicants need to consider the impact of post-grant challenges to the brand holders’ patents, as biosimilar applicants will likely employ such challenges to attack those patents prior to filing their application and prevent them from being asserted in litigation.